FDA Approves Spravato Esketamine Nasal Spray As Monotherapy For Treatment-Resistant Depression

On January 17, 2025, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s Spravato® esketamine nasal spray as a monotherapy for treatment-resistant depression. The new use is for adults with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.

The approval was granted based on results from a randomized, double-blind, multicenter, placebo-controlled study in which Spravato showed a rapid and superior improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score compared to the placebo. After four weeks (28 days), 7.6% of those assigned . . .